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NOT YET RECRUITING
NCT06438939
NA

NBI for Early Diagnosis of OPMD/OSCC

Sponsor: Cardarelli Hospital

View on ClinicalTrials.gov

Summary

Early detection - possibly at its pre-malignant stages (Oral Potentially Malignant Disorders, OPMD) - with periodic surveillance is thus fundamental for limiting disease burden, hopefully reducing the incidence of advanced stages OSCC and increasing survival. Narrow Band Imaging (NBI) has proved itself as promising tool for helping clinician both for diagnosis and therapy. Yet, there is no definitive scientific evidence that NBI is superior to common oral examination with white light (WLOE) for diagnosing OSCC/OPMD. We thus propose a randomised clinical trial understand its role in this field.

Official title: Narrow Band Imaging (NBI) for Early Diagnosis of Oral Squamous Cell Carcinoma (OSCC) and Oral Potentially Malignant Disorders (OPMD)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

480

Start Date

2024-09-30

Completion Date

2026-12-31

Last Updated

2024-06-03

Healthy Volunteers

No

Interventions

OTHER

Biopsy for diagnostical purposes

Incisional biopsy is the current golden standard for OPMD/OSCC diagnosis. Yet, the site it shall be performed is choosen by clinician at naked eyes. We will compare and study the results of performing the common golden standard biopsy site when guided by NBI.

Locations (1)

Agostino Guida

Naples, Italy